MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND DYNAFORCE DYNABUNION; PLATE, FIXATION, BONE

Model Number 15LP-3536

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 04/12/2021

Event Type  malfunction  

Event Description

The surgeon reported that the patient's anti-drift bolt (adb) backed out.The patient originally had lapidus surgery with dynabunion plate and adb on (b)(6) 2020.The patient also had a talonavicular fusion with crossroads staples, plates and screws.The adb was replaced with another screw on (b)(6) 2021.Other hardware was not revised.

Manufacturer Narrative

The surgeon reported that the patient's anti-drift bolt (adb) backed out.The patient originally had lapidus surgery with dynabunion plate and adb on (b)(6) 2020.The patient also had a talonavicular fusion with crossroads staples, plates and screws.The adb was replaced with another screw on (b)(6) 2021.Other hardware was not revised.Non-conformance was not identified based on the lots that would contribute to these events.Screw back-out may have been due to inadequate fixation intra-operatively.The following screws and plates were implanted with the adb and not revised or removed: ref: 7100-lp18-r ln: 501209 qty: 1 product name: dynabunion plate 18mm - right.Ref: 1500-3514 ln: 400032 qty: 1 product name: motoband non-locking screw 3.5mm x 14mm.Ref: 1500-3516 ln: 400083 qty: 1 product name: motoband non-locking screw 3.5mm x 16mm.Ref: 15pl-3514 ln: 450132 qty: 1 product name: motoband polyaxial locking screw 3.5mm x 14 mm.Ref: 7118-1818 ln: 501144 qty: 1 product name: 18x18x18mm himax.

• Brand Name: MOTOBAND DYNAFORCE DYNABUNION
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 11952200
• MDR Text Key: 280782871
• Report Number: 3011421599-2021-00009
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00815432028825
• UDI-Public: 00815432028825
• Combination Product (y/n): N
• PMA/PMN Number: K193452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Model Number: 15LP-3536
• Device Catalogue Number: 15LP-3536
• Device Lot Number: 501167
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR